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Federal Register / Vol. 86, No. 233 / Wednesday, December 8, 2021 / Rules and Regulations
falling out of the device, and insufficient mechanical strength of the device and stair-climbing mechanism.

jspears on DSK121TN23PROD with RULES1

D. Any Changes to the Device Would Not Be Likely to Result in a Change in the Devices Classification Lastly, the petition states that any changes to the devices would not be likely to result in a change in the devices classification. Specifically, the petition states that the device has been on the market for several decades and is well characterized and understood by manufacturers and healthcare professionals. The petition then cites to section 513g of the FD&C Act as a mechanism to obtain the Agencys views about the classification and applicable regulatory requirements for a device that has been significantly changed. As noted above, FDA does not agree with petitioner that the subject devices are well characterized at this time, thus we cannot foresee whether, or what, changes will result in the devices classification. While FDA agrees that section 513g is an appropriate mechanism to obtain the Agencys views about the classification and applicable regulatory requirements of a device, the mere fact that such an optional feedback mechanism exists may only contribute to, but would not guarantee, the reasonable assurance of safety and effectiveness of any particular device. Additionally, because FDA believes that a change to the device would be likely to result in a change in classification, FDA did not evaluate petitioners contention that the limitations on exemption under 21 CFR
890.9 would apply to any changes that do not result in a change in classification. Thus, the petitioners response to this factor does not weigh in favor of exemption from the requirements of premarket notification.
For all the foregoing reasons, the petition failed to demonstrate that premarket notification is not necessary to provide reasonable assurance of safety and effectiveness for the subject device type. Therefore, FDA denied the petition request for exemption from premarket notification requirements for powered patient transport, all other powered patient transport, and is issuing this order setting forth the final determination. Manufacturers of this device type must continue to submit and receive FDA clearance of a 510k submission before marketing their device, as well as comply with all other applicable requirements under the FD&C Act.

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V. Analysis of Environmental Impact The Agency has determined under 21
CFR 25.30h that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
VI. Paperwork Reduction Act of 1995
While this final order contains no new collection of information, it does refer to previously approved FDA
collections of information. Therefore, clearance by the Office of Management and Budget OMB under the Paperwork Reduction Act of 1995 44 U.S.C. 3501
3521 is not required for this final order.
The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR part 820, regarding quality system regulation, have been approved under OMB control number 09100073; the collections of information in 21 CFR part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 09100120; and the collections of information in 21 CFR
parts 800, 801, and 809, regarding labeling, have been approved under OMB control number 09100485.
Dated: December 3, 2021.
Lauren K. Roth, Associate Commissioner for Policy.
FR Doc. 202126636 Filed 12721; 8:45 am BILLING CODE 416401P

DEPARTMENT OF LABOR

NATIONAL FOUNDATION ON THE
ARTS AND HUMANITIES
National Endowment for the Humanities 45 CFR Part 1177
RIN 3136AA38

Claims Collection; Correction National Endowment for the Humanities; National Foundation on the Arts and the Humanities.

AGENCY:

ACTION:

Direct final rule; correction.

The National Endowment for the Humanities NEH is correcting a direct final rule that published November 24, 2021, in the Federal Register. The final rule revised the NEH
Claims Collection regulation in accordance with the Debt Collection Improvement Act of 1996 DCIA, as implemented by the Department of Justice DOJ and the Department of Treasury Treasury in the revised Federal Claims Collection Standards FCCS. NEH discovered two errors after publications that could cause confusion and is correcting those errors in this document.

SUMMARY:

DATES:

Effective February 22, 2022.

FOR FURTHER INFORMATION CONTACT:

Elizabeth Voyatzis, Deputy General Counsel, Office of the General Counsel, National Endowment for the Humanities, 400 7th Street SW, Room 4060, Washington, DC 20506; 202 606
8322; gencounsel@neh.gov.
In FR Doc.
202123742, appearing in the Federal Register of November 24, 2021, starting on page 66964, make the following corrections:

SUPPLEMENTARY INFORMATION:

Occupational Safety and Health Administration 29 CFR Parts 1910, 1915, 1917, 1918, 1926, and 1928
Docket No. OSHA20210007

1177.9

Corrected
RIN 1218AD42

1. On page 66967, in the second column, designate the second paragraph e as paragraph f.

COVID19 Vaccination and Testing;
Emergency Temporary Standard
1177.24

Corrected
2. On page 66973 in the first column, correct the paragraph designations a.
and b. to read as a and b.

Correction In rule document 202126268, appearing on page 68560 in the issue of Friday, December 3, 2021, make the following correction:
On page 68560, in the first column, in the DATES section, on the third and fourth lines, 86 FR 6140 should read, 86 FR 61402.

Authority: 31 U.S.C. 3711, 37163719;
Pub. L. 104134; 31 CFR 900904.
Dated: December 3, 2021.
Samuel Roth, Attorney-Advisor, National Endowment for the Humanities.

FR Doc. C1202126268 Filed 12721; 8:45 am
FR Doc. 202126606 Filed 12721; 8:45 am
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